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NCT04130997 · ClinicalTrials.gov registry record · Phase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
A Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 1,100
- Enrollment target
- 20
- Study locations
NCT04130997: Active Phase 3 study of Relapsing Multiple Sclerosis (RMS), sponsored by TG Therapeutics.
NCT04130997 is a Phase 3 study of Relapsing Multiple Sclerosis (RMS) that is active but no longer recruiting, run by TG Therapeutics. The registered enrollment target is 1,100 participants, above the 430-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (156% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04130997, a Phase 3 study of Relapsing Multiple Sclerosis (RMS), is active but no longer recruiting, sponsored by TG Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
Primary Outcome
ARR is defined as the number of relapses per-participant year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).
Conditions Studied
Interventions
- BIOLOGICAL Ublituximab
Study Locations (20)
Texas
- TG Therapeutics Investigational Trial Site - Dallas
- TG Therapeutics Investigational Trial Site - Frisco
- TG Therapeutics Investigational Trial Site - Round Rock
- TG Therapeutics Investigational Trial Site - San Antonio
Florida
- TG Therapeutics Investigational Trial Site - Miami
- TG Therapeutics Investigational Trial Site - Tampa
Ohio
- TG Therapeutics Investigational Trial Site - Columbus
- TG Therapeutics Investigational Trial Site - Westerville
California
- TG Therapeutics Investigational Trial Site - Pasadena
Colorado
- TG Therapeutics Investigational Trial Site - Denver
Illinois
- TG Therapeutics Investigational Trial Site - Northbrook
Kansas
- TG Therapeutics Investigational Trial Site - Kansas City
Michigan
- TG Therapeutics Investigational Trial Site - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2032-05-31 |
| Phase | Phase 3 |
What the registry record for NCT04130997 still lists
NCT04130997 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 430-participant average among 3 other Relapsing Multiple Sclerosis (RMS) trials with a reported enrollment target (156% higher).
The record links to 1 condition, with Relapsing Multiple Sclerosis (RMS) appearing as the primary indexed condition, and to 1 intervention - of which Ublituximab is the first listed.
NCT04130997 names 20 study sites across 15 states, led by Texas, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT04130997 about?
NCT04130997 is a clinical study titled "An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis". The purpose of this study is to evaluate long-term safety and efficacy of ublituximab therapy in participants with relapsing multiple sclerosis (RMS).
What is the current status of trial NCT04130997?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,100 participants. The study started on 2019-11-18. Estimated completion is 2032-05-31.
What conditions does trial NCT04130997 study?
This clinical trial studies the following conditions: Relapsing Multiple Sclerosis (RMS).
What interventions are being tested in trial NCT04130997?
The interventions under investigation include: Ublituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04130997?
This trial is sponsored by TG Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04130997 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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